Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LZG — Predicate Candidate Screening
84 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
263 days90th percentile
84clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253534 | Pivot Insulin Delivery System | Modular Medical | 2026-04-08 | 146 | 0 |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024-09-04 | 229 | 0 |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | 2024-07-02 | 27 | 0 |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023-04-24 | 171 | 0 |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022-04-06 | 392 | 0 |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Ma | Insulet Corporation | 2021-08-13 | 84 | 3 |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Mana | Insulet Corporation | 2019-10-21 | 26 | 0 |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Mana | Insulet Corporation | 2019-01-08 | 106 | 0 |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018-06-01 | 144 | 0 |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017-04-18 | 245 | 0 |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery Syst | Tandem Diabetes Care, Inc. | 2016-10-25 | 90 | 0 |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016-07-25 | 195 | 0 |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery Syst | Tandem Diabetes Care, Inc. | 2016-07-13 | 142 | 0 |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | 2016-04-27 | 86 | 0 |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015-01-09 | 65 | 0 |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014-12-18 | 93 | 0 |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2014-11-13 | 265 | 0 |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-10-31 | 123 | 0 |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-03-24 | 122 | 0 |
| K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2013-08-29 | 115 | 0 |
| K122483 | PEARL DIABETES MANAGEMENT SYSTEM | Asante Solutions, Inc. | 2013-01-03 | 142 | 0 |
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM | Insulet Corporation | 2012-12-07 | 73 | 8 |
| K111353 | ACCU-CHECK COMBO SYSTEM | Roche Diagnostics | 2012-07-17 | 428 | 3 |
| K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | Medtronic Minimed | 2012-03-29 | 66 | 6 |
| K111669 | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULI | Insulet Corporation | 2011-12-15 | 183 | 0 |
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2011-11-09 | 194 | 1 |
| K100567 | PEARL DIABETES MANAGEMENT SYSTEM | M2 Group Holdings, Inc. | 2011-05-10 | 435 | 0 |
| K103825 | V-GO INSULIN DELIVERY SYSTEM | Valeritas, Inc. | 2011-02-23 | 55 | 0 |
| K100504 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-G | Valeritas, LLC | 2010-12-01 | 282 | 0 |
| K093364 | SOLO MICROPUMP INSULIN DELIVERY SYSTEM | Medingo , Ltd. | 2010-01-25 | 89 | 0 |
| K090245 | SOLO INSULIN PATCH PUMP | Medingo , Ltd. | 2009-07-23 | 171 | 0 |
| K083225 | FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITOR | Abbott Diabetes Care, Inc. | 2009-02-20 | 109 | 0 |
| K082590 | SYMPHONY METER REMOTE | Lifescan, Inc. | 2008-12-17 | 100 | 0 |
| K082595 | MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT | Roche Diagnostics | 2008-10-28 | 50 | 0 |
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | Animas Corp. | 2008-06-24 | 110 | 7 |
| K070844 | NILIMEDIX ADI | Nilimedix , Ltd. | 2008-06-06 | 437 | 0 |
| K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT | Medtronic Minimed | 2008-04-25 | 148 | 0 |
| K071788 | AVIATOR INSULIN PUMP | Abbott Diabetes Care, Inc. | 2008-01-11 | 193 | 0 |
| K071613 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2007-12-14 | 184 | 0 |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | 2007-03-30 | 109 | 0 |
| K063126 | DANA DIABECARE IIS | Sooil Development Co., Ltd. | 2007-02-02 | 112 | 0 |
| K062323 | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLU | Smiths Medical MD, Inc. | 2006-11-01 | 84 | 5 |
| K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MO | Disetronic Medical Systems AG | 2006-06-15 | 76 | 1 |
| K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | Medtronic Minimed | 2006-01-31 | 78 | 4 |
| K051041 | INSULIN PUMP | Abbott Diabetes Care, Inc. | 2005-12-23 | 242 | 0 |
| K050760 | ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics Corp. | 2005-09-13 | 173 | 0 |
| K050971 | BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) | Biovalve Technologies, Inc. | 2005-08-16 | 120 | 0 |
| K050312 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2005-05-09 | 90 | 0 |
| K042887 | ACCU-CHEK SPIRIT | Disetronic Medical Systems AG | 2005-03-18 | 150 | 1 |
| K042792 | IXL-II DIABETES MANAGEMENT SYSTEM | Insulet Corporation | 2005-01-03 | 89 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda